Pressure-sensing compression bandage

ABSTRACT

A pressure-sensing compression bandage having a plurality of pressure sensors provided to indicate the pressures applied by and/or the pressure gradient created by, the applied bandage at various locations along its length when the bandage is applied to a limb or other extremity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/119,999, filed on Feb. 24, 2015, which is hereby incorporated byreference as if fully recited herein.

TECHNICAL FIELD

Embodiments of this application are directed to pressure-sensingcompression bandages.

BACKGROUND

Extremity swelling is a common entity afflicting a large populationworldwide. One common cause of extremity swelling is a buildup of excessfluid in the tissue of the extremity. This buildup of excess fluid isreferred to generally as edema, and frequently results from an increasein capillary permeability that leads to a stasis of extravascular fluidin the extremity. The increase in fluid extravasation may manifest withdolor (pain), calor (heat), hyperemia, decreased range of motion, and/orswelling. Chronic extremity swelling can have deleterious implicationson the healthy maintenance of the surrounding soft tissues and lead toskin break down and ulcers, an ulcer being defined generally as a defectin the skin, often below the knee, that has been present for more thanfour to six weeks. Such health implications can create significantongoing economic burdens on a global scale.

Edema may be attributable to multiple pathologies. Two common but notexhaustive sources of edema in the lower extremities are chronic venousinsufficiency (CVI) and chronic lymphedema. By clinical definition, CVIresults when the venous system of the body can no longer effectivelypump blood back to the heart, or otherwise from a disruption in thevenous system of blood return to the heart. With respect to the lowerextremities, the venous flow travels through three systems or the deep,superficial and communicating venous systems. Blood is moved upwardsfrom the leg to the heart by muscle contraction, such as contractions ofthe gastrocnemius and soleus muscles of the leg. As a result of gravity,pressures change along the course of the leg when in a standingposition. For example, standing pressures at the ankle are usually90-100 mmHg in the venous system. When walking, the pressures fallquickly to around 20 mmHg but return to normal higher pressures withinseconds of movement cessation.

An inability of the body to create such a pressure difference is knownas venous hypertension. Venous hypertension leads to the distension ofthe capillary walls and leakage of various macromolecules from withinthe capillaries into the dermis. This leads to lipodermosclerosis or thecharacteristic ‘woody’ and ‘bruised’ appearance to the skin, and mayultimately result in the development of ulcers in the skin and even celldeath.

Lymphedema results when lymphatic system is unable to recollectinterstitial fluid that has escaped the intravascular space. The mostcommon cause of lymphedema worldwide is the Filarioidea round wormparasite, which causes a condition known as filariasis. Other conditionssuch as congenital deformities, obesity, and radiation can also lead tolymphedema through lymph outflow compromise.

The lymphatic system, among other things, helps to reduce overallpressure in the lower extremities. More particularly, small lymphaticchannels similar to veins capture extravasated fluid produced duringinflammation and filter the fluid through lymph nodes before returningit to the general body circulation near the heart.

Damage to the valves in this system or chronic inflammation may lead tofluid accumulation in the effected extremity, with an inability topassively reabsorb such fluid. Inflammation leads to changes within thevascular structures, possibly leading to vessel dilation and cellulardeath.

It is estimated that CVI leading to lower extremity ulceration has anincidence of 1-4.3% of the Western population, and that 3-4% ofindividuals over the age of 65 manage chronic wounds of the lowerextremity attributable directly to swelling and edema. Another reportstates that the incidence of these problems is as high as 1.2-11.0persons per 1,000 population. Chronic skin related wounds in the UnitedStates affect over 6.5 million people each year.

The actual prevalence of such problems is much higher than indicatedabove, as the average duration of healing time for ulceration from CVIis reported to be over 12 months. It has also been determined thatpersons who develop ulcerations from CVI will experience more than tenepisodes of such ulceration in his or her lifetime. The 12-monthrecurrence rate has been estimated to be between 18-28%, with theoverall 5-year recurrence rate as high as 78% in this population.

It is estimated that lymphedema disfigures and incapacitates over 120million people worldwide. More specifically, and as an example, it hasbeen reported that there are between 3-5 million people in the UnitedStates affected by lymphedema, approximately 40 million in Brazil andHaiti, and around 300,000 in Canada.

Various neuropathies leading to decreased limb mobility and increasedrisk for inflammation or swelling also exist. One such exemplaryneuropathy is Diabetes Mellitus. There are an estimated 347 millionpeople worldwide with type II Diabetes.

Inflammatory disorders such as rheumatologic diseases or pyodermagangrenosum can also lead to lower extremity skin problems and edema.Obesity is recognized as effecting 78 million people in the UnitedStates without an established incidence of associated lymphedema.Pregnancy is associated with silent thrombosis and increased overallintravascular fluid volumes leading to similar clinical symptoms.Extremity trauma has a high positive correlation to phlebitis and venousthrombosis. Lastly, the geriatric population, in general, has higherrates of immobility, decreased pump and muscle function and dependentlower extremity edema as a consequence.

Skin breakdown and ulceration from the above processes are common.Multiple cycles of healing and repeated ulceration comes with arecurrence rate as high 72%. It is common to see related ulcers inpatients lasting over 5 years and labeled as refractory to conventionaltherapies.

Furthermore, the psychological effects of extremity edema, ulcerationand lymphedema are detrimental to the overall quality of life.Psychological distress leading to anxiety, depression and mooddisturbances is well documented and contributes to significantextraneous health care costs. There is also an associated public fear,general stigma and perceived marginalization, all of which may lead tosocial isolation, societal withdrawal and ultimately decreasedfunctional work and productivity. Moreover, lack of social support andcorrelation to concomitant lack of health care further drives up costs.

With respect to costs, chronic wound care in the United States alone isestimated to cost over 25 billion dollars. The average monthly cost foran American with an open wound is $4,095. Of the aforementioned 25billion dollar amount, the treatment of chronic venous ulcer woundsalone is believed to cost approximately 1-2 billion dollars, with thedirect cost of treating each patient amounting to approximately $30,000per year in the United States. Worldwide, CVI and venous ulcers leads toexpenditures of over 7 billion per year in health care costs.

The treatment and management of edema, lymphedema or any other cause ofincreased extravascular fluid extravasation or tissue compromise in anextremity is usually initially approached through extremity elevation.The recommended anecdotal guidelines involve raising legs or arms abovethe heart level for 30 minutes, three to four times a day. As a result,swelling normally subsides over extended periods of time and generalmicrocirculation improves. However, and as should be apparent, atreatment program consisting of such extremity elevation is not alwayspractical.

The next minimally invasive approach to the treatment of such extremityproblems involves compression through bandages, garments, or hosiery.The classification system used to describe this modality depends on theclinical scenario and the associated level of pressure being applied bythe compression article.

Hosiery or compression stockings and other garments, commonly known asTed Hose, involve compression through 1 or 2 layers. In the case of aleg, Class 1 garments involve light support and provide 14-17 mmHg ofpressure at the ankle. Class 1 garments are used to treat varicoseveins. Class 2 garments provide medium support, and produce pressures of18-24 mmHg at the ankle. This class of garments is used to treat moresevere varicosities, and to prevent venous leg ulcers. Class 3 garmentsprovide strong support, or 25 to 35 mmHg of pressure at the ankle. Thisclass of garments is used to treat severe chronic hypertension andsevere varicose veins, and to prevent venous leg ulcers.

A parallel therapeutic intervention involves the use of long stretchelastic bandages or spiral wraps. Note that the terms bandage(s) andwrap(s) are generally used interchangeably by the medical profession(the terminology of choice depending mostly on geography) and,therefore, both terms may be used interchangeably herein and both termsare considered to refer generally to any spirally or otherwise wrappedcompression device for providing multilayered compression of a limb. Theterm “bandage”, when used herein, is not to be construed in a narrowersense as limited to the treatment of a wound.

Multilayered compression bandages also have a grading system. Class 1bandages are known as retention bandages, and are used to retaindressings. Class 2 bandages are known as support bandages, and are usedto support strains and sprains (e.g., an Ace™ wrap). Other bandages inthis category (e.g., the Setocrepe bandage from Mölnlycke) can applymild to moderate compression. Class 3a is subcategorized as lightcompression. Bandages in Class 3a (e.g., the Elset bandage fromMölnlycke) exert 14 to 17 mmHg of pressure at the ankle when applied ina simple spiral. Class 3b bandages apply moderate compression. Bandagesin Class 3b (e.g., the Granuflex® adhesive compression bandage fromConvaTec) apply 18 to 24 mmHg of pressure at the ankle when applied as asimple spiral. Class 3c bandages are defined as generating highcompression. Bandages in Class 3c (e.g., the Setopress bandage fromMölnlycke or the Tensopress bandage from Smith and Nephew) apply 25 to35 mmHg of pressure at the ankle when applied as a simple spiral.Lastly, Class 3d bandages deliver extra high compression. Bandages inClass 3d apply up to 60 mmHg of pressure at the ankle when applied as asimple spiral.

Yet another category of bandages includes the rigid or short stretchbandages which, when used on a leg, are designed to provide sustainedpressures of 40 to 45 mm Hg at the ankle, graduating to 17 mm Hg belowthe knee. Pneumatic compression is another non-invasive interventionthat is gaining greater acceptance for use in the improvement of lowerextremity circulation, and is most often used to prevent deep venousthrombosis in incarcerated or immobile patients. In pneumaticcompression, a pump actively creates air pressure to mechanically forcethe fluids of the extremity in a particular direction.

Ultimately, the four-layer multi-component compression bandage system(four-layer bandage) is still regarded as the gold standard initialcompression system to treat venous leg ulceration and lower extremityedema. It has been found that compression increases ulcer-healing rates.Compression alone is superior to a moist interactive dressing withoutcompression. High compression regimens are more effective than lowcompression. Lastly, adherence to high levels of compression afterhealing reduces the rate of recurrence.

It can be understood from the foregoing observations that limb swellingdue to CVI, lymphedema, etc., as well as the problematic conditions thatmay result therefrom, is prevalent, costly, and may be extremelydebilitating. While compression bandages and their use are known andaccepted for the treatment of swelling, improvements therein are need tooptimize treatment success and to minimize or prevent injuries that maybe caused by the improper application of compression bandages. Exemplarydevices and methods of this application embody such improvements.

SUMMARY

Exemplary embodiments described in the present application are directedto improved compression bandage devices and their methods of use in thetreatment of swelling and/or other conditions. There have beenheretofore few tangible advances in this technology since the concept ofspiral compression bandages was originally described over 200 years ago.

Currently, trained health care providers or equivalent personnel mustapply layered spiral compression bandages consistently andappropriately. When a non-graded application is undertaken, results canbe harmful to the patient as detrimental effects can occur withincorrect application. For example, applying a compression bandage tooloosely in one region may cause tissue fluid to move distally as opposedto a desired proximal direction toward the heart. In contrast, applyinga compression bandage too tightly may result in discomfort,non-compliance and even tissue compromise. Limb ischemia and resultantamputation have been reported in this regard.

With respect to the leg, these difficulties can be attributable at leastin part to the ankle-calf disproportion, i.e., narrow ankles and widecalves. Many studies have shown that application training is necessaryand a learning curve exists for most applicators—with experienceproviding the most reproducible results.

In accordance with the accepted Law of Laplace, an evenly appliedpressure will be higher in the ankle than the calf due to the radius(correlation to girth) of the location being wrapped. This is a majorproblem with hosiery, as the ‘one size fits all’ concept does nottranslate globally. Rather, arriving at a desired universal gradedpressure distribution would require an established pressure-girthprofile. Unfortunately, people have extremity thicknesses that changewith both gender and age—making the successful use of a universal gradedpressure distribution virtually impossible.

Exemplary device and method embodiments described herein remove anyguesswork and analysis of limb morphology by allowing a greaterpopulation of consumers and patients access to more consistent pressureapplication. More particularly, exemplary device and method embodimentsof the invention improve upon conventional compression bandages and theuse thereof by providing a comfortable, reusable, and low cost,pressure-sensing compression bandage that is able to deliver consistentand observable pressure readings to a user through user-friendlyinterfaces. Both patients and health care providers will benefit fromthe ease of application and use resulting from the pressureinterrogation and reporting provided by said devices.

Exemplary device embodiments are, generally speaking, multilayered,pressure-sensing compression bandages that allow a user to providegraded pressure to an extremity during bandage application. The creationof a graded pressure is produced by applying the same compression evenlyalong the extremity as the girth of the extremity changes. Resultantly,for example, the same applied compression over the calf will provideless transmitted pressure than the ankle, which has less overall girth.

The exemplary compression bandage embodiments described hereinpreferably include multiple layers, such as but not limited to a comfortlayer to be located at or near the skin surface, an elastic compressionlayer, and a sensor layer. An optional custom insert/layer may also forma localized, intermittent or continuous layer along the interior surfaceof the comfort layer for the purpose of, without limitation, fluidabsorption, improving wound or scar healing, or other therapeuticpurposes. One exemplary compression bandage embodiment may be comprisedof five distinct layers: a therapeutic innermost layer, a comfort layer,a pressure/temperature sensing area disposed along the comfort layer, agraded elastic layer, and an outer layer containing markings/colors toguide a user in creating a proper overlap of the compression bandageduring application. Each of the aforementioned and exemplarypressure-sensing compression bandage layers may be comprised of variousmaterials, as will be described in more detail below.

A sensor assembly is also present and preferably includes a series ofspaced apart pressure sensors that are attached to or embedded in a meshmaterial or some other suitable fabric, etc., such as for example, to/inthe material forming the comfort layer. Alternatively, the sensors maybe trapped between one material layer and an adjacent material layer(e.g., a comfort layer and overlying elastic compression layer, or anouter layer and an underlying elastic compression layer).

The sensors of an exemplary compression bandage are preferably arrangedsuch that the sensors will be located at spaced apart intervals alongthe length of an extremity as the compression bandage is applied to theextremity. Consequently, the sensors are able to detect and report thepressures applied by the bandage at various locations along the lengthof the extremity.

In use, the sensors will report pressure readings to amonitor-controller, which may be a fixed device in a clinic, etc., or aportable device that may be small enough for handheld use and/or forwearing or carrying by a patient to which an exemplary pressure-sensingcompression bandage is applied. In an exemplary embodiment, amonitor-controller may be removably attached to a pressure sensingcompression bandage and connected to the sensors and associatedcircuitry thereof after application of the bandage to a patient.

An exemplary monitor-controller may display readings from the pressuresensors in any manner that allows a user to understand the pressurereadings or the pressure gradient produced by the pressure-sensingcompression bandage. For example, and without limitation, a pressuregradient may be displayed in various colors that represent underpressure, ideal pressure, and excess pressure areas or zones along thelength of the applied pressure-sensing compression bandage.

The monitor-controller may include a microprocessor, memory,communications elements, corresponding programming and/or software,and/or any other components necessary to produce the desired operationand interaction between the monitor-controller and a pressure-sensingcompression bandage. Communication between the monitor-controller and apressure-sensing compression bandage may be wired or wireless in nature.A mobile device application may also be provided on a mobile device andmay communicate with the monitor-controller, accept data from themonitor-controller, or comprise the monitor-controller and itsfunctionality. For example, the sensors on the pressure-sensingcompression bandage may communicate wirelessly with a mobile device todisplay the pressure gradient and/or other information.

An alerting function may also be provided if the pressure applied by anassociated pressure-sensing compression bandage drops below or exceedssome preset ideal pressure or range of pressures. Alerts may be providedto the patient and/or to a health care provider. Pressure data may berecorded.

Other aspects and features will become apparent to those skilled in theart upon review of the following detailed description of exemplaryembodiments along with the accompanying drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

In the following descriptions of the drawings and exemplary embodiments,like reference numerals across the several views refer to identical orequivalent features, and:

FIG. 1A illustrates one exemplary embodiment of a pressure-sensingcompression bandage being applied to an extremity in the form of a humanlower leg;

FIG. 1B is an enlarged view of the pressure-sensing compression bandageof FIG. 1A in a rolled up and pre-applied form;

FIG. 2 is an exploded view depicting various possible layers of oneexemplary pressure-sensing compression bandage;

FIG. 3 is an unrolled view of several layers of one exemplarypressure-sensing compression bandage illustrating the presence of acomfort layer that is sandwiched between an inner, targeted therapeuticinsert, and a superjacent elastic layer;

FIG. 4 is a detailed view of the construction of an exemplary elasticlayer of one exemplary pressure-sensing compression bandage;

FIG. 5 schematically illustrates an exemplary sensor circuitry layout ofone exemplary pressure-sensing compression bandage sensor assembly;

FIG. 6 schematically illustrates an exemplary receptor circuitry layoutof one exemplary pressure-sensing compression bandage sensor assembly;

FIG. 7A schematically represents the various unassembled components ofan exemplary sensor assembly construction of one exemplarypressure-sensing compression bandage;

FIG. 7B schematically illustrates the components of FIG. 7A in anassembled state;

FIG. 8 schematically illustrates one exemplary outer layer of anexemplary pressure-sensing compression bandage;

FIG. 9A illustrates one exemplary embodiment of a pressure-sensingcompression bandage applied to an extremity in the form of a human lowerleg;

FIG. 9B is an enlarged view of an exemplary monitor-controller that isremovably attached to the pressure-sensing compression bandage of FIG.9A;

FIG. 10A-10C depict various exemplary display screens that may bepresented to a user of a pressure-sensing compression bandage asdescribed herein;

FIGS. 11A-11B depict alternative or additional exemplary display screensthat may be presented to a user of a pressure-sensing compressionbandage as described herein;

FIGS. 12A and 12B depict alternative embodiments of a pressure sensingdevice for application to a limb of a user/patient.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIG. 1A illustrates the application of one exemplary embodiment of apressure-sensing compression bandage 5 to a limb in the form of a humanlower leg 10. As shown in FIGS. 1A-1B, the pressure-sensing compressionbandage 5 may be initially provided in a rolled up form for easy storageand application. The pressure-sensing compression bandage 5 may includean overlap indicator 15 (as represented by the dashed line) that assiststhe applier of the pressure-sensing compression bandage with properwrapping thereof. The inclusion and use of an overlap indicator/markingis described in more detail below.

As also depicted in FIG. 1B, the pressure-sensing compression bandage 5may include a monitor-controller 20. In this example, themonitor-controller 20 may be employed to provide a user withpost-application information relating to, for example, the pressureapplied to the limb 10 by the pressure-sensing compression bandage, theskin temperature along different points of the limb underlying thepressure-sensing compression bandage, etc. As shown in FIG. 1B, themonitor-controller may come pre-connected to the pressure-sensingcompression bandage 5.

Exemplary pressure-sensing compression bandage embodiments, such as thepressure-sensing compression bandage 5 of FIGS. 1A-1B, preferablyinclude multiple layers, as shown in FIG. 2. These layers may includebut are not limited to a comfort layer 25 to be located at or near theskin surface, an elastic compression layer 30, and an outer layer 35. Anoptional custom insert 40—such as a therapeutic insert—may form alocalized, intermittent or continuous layer along the interior(skin-facing) surface of the comfort layer 25. Other numbers andcombinations of layers are possible in other embodiments. For example,another exemplary pressure-sensing compression bandage embodiment may becomprised of five distinct layers: a therapeutic innermost layer orinsert, a comfort layer, a pressure/temperature sensing layer disposedalong the comfort layer, a graded elastic layer, and an outer layercontaining markings/colors to guide a user in creating a proper overlapof the pressure-sensing compression bandage during application.

The comfort layer of exemplary pressure-sensing compression bandageembodiments may be comprised of, for example, one or combinations ofcotton, foam, gel, silicone, elastane (e.g., Lycra®), nylon, spandex,viscose, velour or other suitable and preferably stretchable materials.Exemplary comfort layers may also include on the skin-facing surfacethereof a coating, stripe or stippled pattern of an adhesive, such asbut not limited to a silicone adhesive, to prevent slippage and therebyallow the associated pressure-sensing compression bandage to bepositioned on a limb without malpositioning or movement of the bandage.A silicone or similar adhesive can produce mild adhesion even whenplaced against macerated skin or exudates from a chronic wound. Theapplied silicone or other adhesive thickness should be thin enough(e.g., less than 1 mm) so as not to detrimentally affect the overallelasticity of the pressure-sensing compression bandage.

As mentioned above, a custom insert may form a localized, intermittentor continuous layer along the interior surface of the comfort layer. Asshown in FIGS. 2 and 3, the custom insert of the exemplarypressure-sensing compression bandage 5 is a therapeutic insert 40. Thetherapeutic insert 40 may be positioned along a 1^(st), 2^(nd), and/orfinal 3^(rd) of the pressure-sensing compression bandage to allow forwound area coverage along all possible positions on the treated limb.The therapeutic insert 40 may include a mild adhesive on its back sideto facilitate retention on the comfort layer 25 while also permittingremoval, replacement or repositioning of the insert. Although not likelynecessary, the therapeutic insert 40 may be a therapeutic layer thatcovers the entire or substantially the entire interior surface of thecomfort layer 25.

The therapeutic layer may carry or be impregnated with various materialssuch as, but not limited to, silicone and/or a steroid to aid in scarhealing, zinc to aid in wound healing, an antimicrobial (e.g., silver)to reduce bacterial load, alginate to assist with fluid absorption, anenzymatic and/or a biologic.

As described above and illustrated in FIG. 2, exemplary pressure-sensingcompression bandage embodiments include at least one, and preferably aplurality, of pressure sensors. In the schematically-depictedpressure-sensing compression bandage construction of FIG. 2, the sensorsare indicated as being carried on or embedded in the comfort layer 25,such that the sensors are in close proximity to the skin of a limbsubsequent to the pressure-sensing compression bandage being appliedthereto. However, it may also be possible to attach, embed or otherwiseassociate the sensors with another layer of a given pressure-sensingcompression bandage. Alternatively, the sensors may be part of aseparate sensor layer, which may include a mesh material, or some othersuitable fabric or other material that is compatible with the sensorsand their attachment thereto or embedment therein.

The elastic compression layer of exemplary pressure-sensing compressionbandages may be comprised of, for example and without limitation,polyurethane, methylmethacrylate, polyethylene, silicone,polyvinylchloride, polyester, rubber or any other suitably stretchablematerial. Preferably, but not necessarily, the material forming theelastic layer can be stretched up to 20%, with return of form followingstretch.

The elastic compression layer of exemplary pressure-sensing compressionbandages may also contain antimicrobial substances such as zinc oxide orchlorhexidine. When present, chlorhexidine may be bound to the elasticmaterial and used to reduce microbial load when placed in a contaminatefield or wound. Chlorhexidine may also be placed in the adhesives thatbind the layers of an exemplary pressure-sensing compression bandage soas to impart both bacteriostatic and bactericidal properties to thebandage. Chlorhexidine may also be used in a therapeutic layer in theform of a dressing such as seen in Chlorderm (Entrotech Life Sciences,San Francisco, Calif.).

One exemplary construction of an elastic layer 45 of a pressure-sensingcompression bandage is schematically represented in FIG. 4. In thisembodiment, the material of the elastic layer differs in constructionover its length. Particularly, this exemplary elastic layer 45 includesthree areas 45 a, 45 b, 45 c of differing elasticity. In this example,the three areas 45 a, 45 b, 45 c of differing elasticity are located torespectively span the distance between the foot and the knee of a humanleg when the pressure-sensing compression bandage is applied thereto,with the area 45 c of lowest elasticity located near the foot and thearea of highest elasticity 45 a located near the knee. Other elasticlayer constructions are, of course, also possible.

The areas 45 a, 45 b, 45 c of differing elasticity are produced, in thisexemplary embodiment, by selectively imparting the elastic material withperforations of different sizes and or number. The spacing and number ofperforations may be sequentially increased or decreased to change theamount of stretch in the elastic layer. More perforations will createless tension with even application than the portion of the garment thathas less perforations with the equivalent applied tension. For example,in the elastic layer 45 embodiment represented in FIG. 4, diamondperforations 50 of larger size and/or frequency are applied to the areaof elasticity 45 a that will be closest to the knee portion of thepressure-sensing compression bandage, elliptical perforations 55 ofslightly smaller size and/or frequency are applied to the intermediatearea 45 b, and yet smaller or less frequent perforations 60 of someshape are applied to the area of least elasticity 45 c that will beclosest to the foot portion of the pressure-sensing compression bandage.Other perforation shapes may also be possible, however, it is noted thatthe use of elliptical or diamond-shaped perforations ensures that withstretch, there is no bunching of the materials at the ends of theperforation that might limit user comfort. It has been determined thatresulting pressures of between, for example, 0 mm Hg and 60 mm Hg areachievable when employing such a technique to manipulate the elasticityof the elastic layer material.

The outer (comfort/application) layer of exemplary pressure-sensingcompression bandages may be comprised of, for example and withoutlimitation, one or a combination of elastane (e.g., Lycra®), polyester,nylon, cotton, velour, and carbon, or one or a combination of othersuitable materials. As described in more detail below, the outer layermay also include design features that facilitate consistent andreproducible application of the associated pressure-sensing compressionbandage.

A more detailed understanding of the sensor technology of one exemplarypressure-sensing compression bandage may be achieved by referring to theprevious disclosure in combination with FIGS. 5-7B. As previouslyexplained, exemplary pressure-sensing compression bandages preferablyinclude a series of spaced apart pressure sensors that are attached toor embedded in a comfort layer (or another bandage layer) or a separatesensor layer comprising a mesh material or some other suitable fabric,etc. Alternatively, the sensors may be trapped between one materiallayer and an adjacent material layer (e.g., a comfort layer and anoverlying elastic compression layer).

FIGS. 5-6 schematically represent the layout of cooperating circuitryportions of one exemplary sensor assembly of an exemplarypressure-sensing compression bandage. It can be understood from FIGS.5-6 that sensors are arranged such that as an associatedpressure-sensing compression bandage is wrapped around an extremity(e.g., a human leg as indicated in FIG. 1), the sensors will be locatedat spaced apart intervals along the length of the extremity.Consequently, the sensors are able to detect and report the pressuresapplied by the pressure-sensing compression bandage at various locationsalong the length of the extremity (e.g., the foot, ankle, calf, andknee). The number of sensors utilized and the spacing between sensorsmay vary depending on, for example, the length of the pressure-sensingcompression bandage, the length of the extremity to which the bandagewill be applied, and the number of different areas along the extremityfor which a pressure reading is desired.

As can be understood from FIGS. 5-7B, this exemplary sensor assemblyincludes various circuitry, which cooperates to produce the desiredpressure (and possibly temperature) readings during use of an associatedpressure-sensing compression bandage. The sensor assembly may reside onthe comfort layer of an exemplary pressure-sensing compression bandage,but other locations are also possible, as explained above. Referring toFIGS. 5-6, it may be observed that three spaced apart sensors are usedin this exemplary embodiment.

In this particular example, the included pressure sensors are of a forcesensing resistor (FSR) type. The resistance of a FSR will vary inaccordance with the amount of pressure that is applied to its sensingarea. Therefore, a FSR is well-suited to measuring pressures or changesin pressure created by the application of a compression bandage to alimb/extremity. Furthermore, a FSR type sensor may require less than 5Vto operate—meaning that power requirements are minimized. While thisexemplary sensor assembly utilizes a FSR, it should be realized thatother types of sensors are also usable, such as but not limited to,sensors of piezoelectric or strain gauge design.

While FSRs may be obtained in pre-existing form, the FSR sensors used inthis particular example are created by printing the components thereofonto a substrate using a conductive polymer or other conductive materialin the form of an ink. When used, such an ink may be comprised of, forexample, a conductive polymer such as but not limited to polyacetylene,polypyrrole, or polyaniline, a piezoresistive substance, or a dielectricmaterial. A suitable conductive ink may also be comprised of silver,silver chloride, carbon, or other materials that can be screen or laserprinted onto substrates. An example of a latter type of such an ink isthe Cl-1036 silver ink distributed by Engineered Conductive Materials,in Columbus, Ohio.

The substrate of such an embodiment may be comprised of a variety ofmaterials including but not limited to fabrics and films. In theillustrated exemplary embodiment, the substrate employed is a thin filmof polyethylene terephthalate (PET).

One portion 65 of the provided exemplary sensor assembly circuitry isschematically illustrated in FIG. 5. As shown therein, an active area(i.e., a pattern of conductors) 70 a, 70 b, 70 c of each FSR sensor isprinted, such as described above, onto a first PET substrate 75. Theactive areas 70 a, 70 b, 70 c are placed in electrical continuity withcorresponding flexible electrical conduits 80 that may also be createdby the printing thereof onto the PET substrate 75. The flexibleelectrical conduits 80 act as the leads that will carry signals producedby the assembled pressure sensors to a connector 85, which is adapted tocouple the sensors to a monitor-controller or other display and/orcontrol device.

The flexible nature of the electrical conduits 80 ensures that there isno increase in resistance and resultant loss of sensitivity at thesensor-circuit interface. The flexible nature of the electrical conduits80 also eliminates any discomfort that might be imparted to a user ifthe conduits were comprised of metal wires and, unlike wires, are farless limiting on the elasticity possessed by the associatedpressure-sensing compression bandage.

A cooperating portion 90 of the provided exemplary sensor assembly isschematically illustrated in FIG. 6. As shown therein, a series ofspaced apart receptor areas 95 a, 95 b, 95 c are located on a second PETsubstrate 100. The receptor areas 95 a, 95 b, 95 c are located andarranged on the second substrate 100 to correspond with the active areas70 a, 70 b, 70 c on the first substrate 75 upon assembly of the sensors(as described in more detail below). As with the active areas 70 a, 70b, 70 c and the electrical conduits 80 of the first portion of thesensor assembly, the receptor areas 95 a, 95 b, 95 c may be printed ontothe second PET substrate 100. Other known techniques for creating thereceptor areas 95 a, 95 b, 95 c on the second substrate 100 are alsopossible.

A better understanding of the assembled exemplary sensor assemblydescribed and shown herein may be had by further reference to FIGS.7A-7B. As may be observed therein, the first portion 65 and secondportion 90 of the sensor assembly 105 are located to one another in amirrored relationship such that the active areas 70 a, 70 b, 70 c on thefirst substrate 75 and the receptor areas 95 a, 95 b, 95 c on the secondsubstrate 100 are aligned, in close proximity, and facing each other, tothereby form individual pressure sensors.

A separator layer 110 is located between the first substrate 75 and thesecond substrate 100. The separator layer 110 is of a thickness selectedto produce an air gap 115 between the active areas 70 a, 70 b, 70 c andcorresponding receptor areas 95 a, 95 b, 95 c of each pressure sensorwhen an associated pressure-sensing compression bandage is in a relaxed(unapplied state). The air gap 115 ensures that the sensors will notproduce pressure readings until the associated pressure-sensingcompression bandage is wrapped around a limb and applies a pressure tothe underlying limb tissue.

As illustrated in FIGS. 7A-7B, the separator layer material surroundsbut does not intrude into the space between the active areas 70 a, 70 b,70 c and corresponding receptor areas 95 a, 95 b, 95 c of each pressuresensor. The separator layer 110 may be comprised of a non-conductivefoam, polyurethane, or other compressible material that will permitcompression of the pressure sensors upon application of an associatedpressure-sensing compression bandage to the limb/extremity of a user.The separator layer material may be air permeable and/or may be ventedto permit the escape of any air trapped between the active areas 70 a,70 b, 70 c and corresponding receptor areas 95 a, 95 b, 95 c of thepressure sensors upon compression thereof.

Once the various electrical components of the pressure sensors areprinted or otherwise applied to the substrates 75, 100, the substratesmay be die cut, laser cut, or otherwise trimmed if desired to minimizethe size of the sensor assembly 105. It may also be possible to sodimension the substrates 75, 100 prior to applying the electricalcomponents thereto.

Once the first portion 65 and second portion 90 of the sensor assembly105 are properly arranged with respect to one another, with theseparator layer 110 appropriately positioned therebetween, the adjacentfaces of the substrates may be joined to produce a sealed,water-resistant sensor assembly. Joining of the substrates 75, 100 maybe accomplished by any know technique, such as but not limited to, heatlamination. The sealed sensor assembly 105 may then be properlypositioned on and attached to or embedded in a selected layer (e.g., thecomfort layer) of an associated pressure-sensing compression bandage.For example, and without limitation, the sealed sensor assembly 105 maybe attached to a layer of a pressure-sensing compression bandage by heatlaminating one of the PET substrates 75,100 thereto.

In some exemplary embodiments of a pressure-sensing compression bandagethat employs FSR-type pressure sensors, an area of more rigid material(not shown) may be associated with one or both of the active andreceptor areas of the FSR. For example, pieces of rigid material may bebonded to or embedded in the substrate(s) to overlie the active areasand/or receptor areas. When present, the rigid material may assist intransferring the compressive forces generated by application of theassociated pressure-sensing compression bandage to the pressure sensors.

In operation of the exemplary FSR pressure sensors subsequent toattachment to an associated pressure-sensing compression bandage,wrapping of the bandage around a limb/extremity produces a compressiveforce that causes a compression of the separator material 110 andapplies pressure to the pressure sensors. In the case of apressure-sensing compression bandage that employs FSR-type pressuresensors, this pressure produces contact between the active areas andreceptor areas of the FSRs which alters the resistance thereof.Increased pressure will cause a greater portion of the active area tocontact the receptor area of a given FSR, which further reduces theresistance of that FSR. Signals indicative of FSR resistance and changesin FSR resistance are received by a monitor-controller that is connectedto the sensor assembly and converted into pressure readings, as isdescribed in more detail below in conjunction with FIGS. 9-11.

In any exemplary pressure-sensing compression bandage embodiment whereinprinting is used in the manufacture of the associated pressure sensors,the thickness of the conductive material (e.g., ink) circuitry may bebetween, for example, 7-15 μm along the circuit length. The electricalresistance associated with such printed conductive circuitry is expectedto be extremely low.

Furthermore, printed conductive material circuitry may be applied to asubstrate or directly to a bandage layer in a non-linearorientation/pattern, such that stretching of the associated layer of apressure-sensing compression bandage will not increase the resistance ofthe circuit, which could undesirably limit the sensitivity of thepressure sensors. Possible, but non-limiting conductive conduit patternsmay include a ladder or grid pattern (i.e., horizontal and verticalprinting) or a wavy or zig-zag pattern, to allow for stretch in both thehorizontal and vertical directions while still permitting maximalconductive material-to-substrate contact.

Printed sensor elements may also be of various configuration andorientation. For example, the active and/or receptor areas of anexemplary FSR sensor may have interdigitating fingers, as shown in FIGS.5-6. Likewise, the design of a given pressure sensor may be square,circular, serpiginous, or of another shape that helps the sensor toconform to the body part with which an associated pressure-sensingcompression bandage will be applied.

In an alternative embodiment, a FSR sensor may be placed on a domecomposed of, for example, polyurethane or an equivalent or similarplastic polymer material, to replace the spacer layer of FIG. 7B whilestill providing a gap between the active and receptor elements of theFSR.

It is typically desirable that a pressure-sensing compression bandage beapplied in a spiral with approximately a 50% overlap between turns, asthis results in a double layer bandaging at any point, and allows forpredicable sustained pressures to be attained. The equation thatsupports this idea is the Law of Laplace, where P=(TNK)/CW, P representsthe sub-bandage pressure (mmHg), T is the bandage tension (kg of Force),C is the circumference of the limb (cm), W is the bandage width (cm), Nis the number of layers applied, and K is the constant value of 4620.

To this end, FIG. 8 represents one possible construction of an outerlayer 120 of an exemplary pressure-sensing compression bandageembodiment that is designed to facilitate proper wrapping. As shown,this outer layer 120 is color coded in a manner where approximately 50%of the outer layer includes a notifying color 125 (green in thisexample) and, optionally, a mild adhesive, the goal of the user being tocover the notifying layer with each pass so as to ensure a consistentoverlap, and the function of the adhesive to retain the overlappedportion of the bandage. The other 50% or so 130 of the outer layer iscomprised of another color, such as nude, navy, black, gray or someother color of choice. In this example, a dissimilarly colored (e.g.,red) indicator 135 is also present to notify the user of the location ofa therapeutic insert so that the insert can be properly positioned overa wound, scar, etc., to be treated. The outer layer may also be labeled150 to direct proper pressure-sensing compression bandage orientation.For example, one end may be labeled “knee” and the other end labeled“foot” when the bandage is designed for application to a leg. Anindication of which end of the bandage is to be applied more tightly mayalso be provided.

Other outer layer markings or indicators for helping to ensure aconsistent overlap is attained when applying an exemplarypressure-sensing compression bandage are also possible. For example, thecolor coded scheme of FIG. 8 could be replaced with a simple dividingline, as is depicted in FIG. 1

In use, the sensors will report pressure readings to amonitor-controller, one non-limiting example 155 of which is representedin FIGS. 9A-9B. An exemplary monitor-controller for use with anexemplary pressure-sensing compression bandage may be a fixed locationdevice, such as in a clinic, etc. Alternatively, and as illustrated inFIGS. 9A-9B, a monitor-controller 155 may be a portable device that issmall enough for handheld use and/or for wearing or carrying by a userto which an exemplary pressure-sensing compression bandage is applied.

In the particular example depicted in FIGS. 9A-9B, themonitor-controller 155 is removably (or permanently) attached to anassociated pressure-sensing compression bandage 160. Themonitor-controller 155 is also connected to the sensor assemblycircuitry of the pressure-sensing compression bandage 160, such as forexample by a connector like that shown in FIG. 5.

A monitor-controller may display readings from pressure sensors in amanner that allows a user to understand the pressure gradient producedby the pressure-sensing compression bandage. For example, as indicatedin FIG. 9A, the pressure gradient may be displayed in various colorsthat are able to represent under pressure, ideal pressure and excesspressure conditions. For purposes of illustration, each of an underpressure zone 165, an ideal pressure zone 170, and an excess pressurezone 175 are represented on the monitor-controller display of FIG. 9B.

Other exemplary and non-limiting displays associated with apressure-sensing compression bandage are presented in FIGS. 10A-10C. Forexample, FIG. 10A represents a basic display of information, such asperhaps a first display screen, which simply indicates to the user thatthe pressure-sensing compression bandage from which reading are beingreceived is located on the right calf of the user. The display of FIG.10B is representative of an alternative version of the display of FIG.9B. That is, different pressure zones are again indicated by differentcolors, but the associated limb is presented from another perspectiveand numerical pressure values are also presented for each pressuresensing zone. The display of FIG. 100 is similar to that of FIG. 100,but also indicates that the sensor nearest the user's foot (Sensor 1) isnot reading properly, suggesting that the tightness of thepressure-sensing compression bandage needs to be adjusted along thatarea of the user's limb. Temperature changes along a pressure-sensingcompression bandage may also be displayed.

An exemplary monitor-controller may include a microprocessor, memory,communications elements, corresponding programming and/or software,and/or any other components necessary to produce the desired operationand interaction between the monitor-controller and a pressure-sensingcompression bandage. Communication between the monitor-controller and apressure-sensing compression bandage may be wired in nature, or may bewireless in nature such as via Bluetooth® or another suitable wirelesscommunication protocol such as WiFi or Near Field Communications (NFC).

A mobile device application may also be provided on a mobile device andmay communicate with the monitor-controller, accept data from themonitor-controller, or comprise the monitor-controller and itsfunctionality. For example, the sensors on a pressure-sensingcompression bandage may communicate in a wired or wireless manner with amobile device to display a pressure gradient and/or other information(see, e.g., FIGS. 10A-10C). The mobile device may be a mobile phone.However, other mobile devices such as tablets, etc., may also be used inthis manner.

An alerting function may also be provided if the pressure applied by anassociated pressure-sensing compression bandage drops below or exceedssome preset ideal pressure or range of pressures. Alerts may be providedto the patient and/or to a health care provider by way of amonitor-controller, mobile device, or another device in communicationwith the sensors of the pressure-sensing compression bandage.

An exemplary pressure-sensing compression bandage may report pressuresor pressure gradients in real time—even as the pressure-sensingcompression bandage is being applied. As represented by FIGS. 11A-11B,another feature of an exemplary pressure-sensing compression bandageincludes the recording, storing and presentation of historical pressuredata. The pressure data may be used for any beneficial purpose by thepatient and/or a health care provider. For example, historical pressuredata may be used to determine if the pressures applied by apressure-sensing compression bandage remain within an acceptable rangethroughout the day or if fluctuations occur due to changes in limb sizedue to activity, temperature, etc.

Exemplary pressure-sensing compression bandages be directed towardsquick and efficient monitoring of the pressures under the bandage. Analert may be created when a particular pressure threshold is eitherexceeded or not met. Alerts can be set to occur, for example, whenexcessive pressures over 30 mm Hg have existed for greater than twohours, so that such excessive pressure can be alleviated to preventischemic conditions. Ranges of acceptable pressures may be customized toan individual to provide maximum comfort while still maintaining gradedpressure to help with blood flow up the extremity. This can be observedby the individual or anyone (e.g., a health care provider) who hasaccess to a connected monitor-controller, mobile device and associatedapplication, etc. Pressures can also be tracked, graphed and trended toshow how long a given pressure-sensing compression bandage was placed ina beneficial therapeutic range to tailor wound healing rates to anindividual. Such information may also be used to gauge how much longerthe use of a pressure-sensing compression bandage will be required toimprove a particular clinical scenario.

Data stemming from the widespread use of pressure-sensing compressionbandage embodiments and associated programs/software may also be minedto provide data for other clinical scenarios. For example, data obtainedfrom the use of pressure-sensing compression bandage embodiments totreat edema, etc., may be used to provide normative data for otherapplications, such as, but certainly not limited to, the therapeutic useof compression in the treatment of scarring or burn wounds, the use ofcompression in athletic apparel (e.g., running apparel), or as anindicator of muscle compliance (e.g., when a muscle is optimally‘warmed’ up and ready for increased stress) to aid in the prevention ofinjury.

The proper compression provided by pressure-sensing compression bandageembodiments will improve edema and facilitate wound healing through themechanical movement of fluid, resulting in the improvement of the venouspump and lymphatic drainage. This can reduce erythrocyte and leukocyteaggregation, with limitation of capillary plugging and vascularcompromise to the soft tissue. In short, pressure-sensing compressionbandage embodiments permit optimization of compression application whilegreatly minimizing or eliminating any potential damage to the compressedtissue due to inappropriate wrapping pressure.

While somewhat counterintuitive, the use of a pressure-sensingcompression bandage to apply pressure to a limb may also improve bloodflow. In fact, studies have shown that O₂ partial pressures at the skinincrease after compression. Cutaneous blood flow may be reduced, butlowering of edema by compression ultimately increases cutaneous bloodflow. Moreover, creating a relative hypoxic state through compressionmay promote angiogenesis (the forming of blood vessels). It has alsobeen demonstrated that increased fibrinolysis reduces the release ofmacromolecules into the extravascular space and prevents trapping ofmediators important to wound healing.

Pressure-sensing compression bandage embodiments may also be employed inmore invasive interventions to address skin breakdown, infection andulceration, such as by applying topical medications in conjunction witha pressure-sensing compression bandage. Wound debridement can occurpassively through autolytic, chemical, mechanical, surgical, andbiologic dressings. Examples of autolytic therapies include collagenase,trypsin and fibrinolytic topicals. Fluid exudate from wounds can bemanaged with alginates and foams. Moist environments to optimizeepithelialization can be improved with application of hydrogels,hydrocolloids, and semipermeable films.

Wound healing augmentation can occur with the addition of certain growthfactors such as platelet-derived growth factor, tissue plasminogenactivator, human recombinant epidermal growth factor, and/orgranulocyte-macrophage colony-stimulating factor. Increased vascularityhas been shown to improve with the use of papain enriched dressings,Stanozolol, and pentoxifyllin. Biological dressings using living cellsboth from the individual patient or alloplastic materials to providetissue engineered skin are also becoming more prevalent. Still in thelaboratory phase, but possibly not too far from use, are autogenous stemcell enriched dressings. Examples of application of progenitor cells,such as fat stem cells or ASCs with multiple differential capacities,have shown much wound healing improvement in the animal models.

While the exemplary embodiments described above and illustrated in thedrawing figures are directed to a pressure-sensing compression bandage,it is contemplated that the associated technology will be applicable toother devices and treatments. Non-limiting examples of such devices andtreatment methodologies include a pressure-sensing cast/splint liner,surgical pressure monitoring, pressure monitoring of intubated patients(e.g., at the occiput of the head or the sacral area), upper extremitycompression, post-surgical or plagiocephaly helmets, custom (arm, hand,ankle) sports wraps, prosthetics (e.g., compression of residuum swellingto fit a prosthesis), the treatment of DVT prophylaxis, and inveterinary medicine.

Of particular note in regard to veterinary medicine is the possible useof pressure-sensing compression bandage technology in equine care andmaintenance. For example, a pressure-sensing compression bandage may beplaced on the leg or thigh of a horse and information about muscleperfusion can be observed. As resistance in the blood vessels change,the overall pressure under the dressing will change. When blood isshunted away from muscles toward vital organ structure (i.e. brain,kidneys), an increase in blood vessel resistance will result in a dropin overall pressure to the system. This may alert a trainer or othercare taker that the risk of muscle injury is high. The return ofpressures under the pressure-sensing compression bandage to baseline oractually higher pressures than initially seen will notify the caretakerthat the muscle is better perfused and warm enough for increasedexercise. A large increase in pressure seen under the pressure-sensingcompression bandage may indicate that a muscle is fatigued anddetrimental byproducts of anaerobic oxygenation (i.e., lactate, CO₂,etc.) may lead to muscle strain or injury.

Other contemplated and non-limiting possible uses include theapplication of a pressure-sensing compression bandage prior to airtravel in order to reduce edema as well as to indicate when a user mayneed to get up and ambulate on long flights. A pressure-sensingcompression bandage may also be used under splints to indicate if areasprone to skin breakdown (e.g., the elbow or heel) are experiencingexcessive pressure. Pressure changes may also alert a user of excessivepressures and indicate a needed loosening of a splint to prevent painand discomfort.

An alternative embodiment of a pressure sensor equipped wearable device200, 200′ is presented in FIGS. 12A-12B. In this embodiment, asensor-equipped fabric layer 205, 205′ is applied to a limb 210, 210′ toultimately position the included sensors 215, 215′ over a particulararea of interest. For example, in trauma patients such as thosesustaining fractures to the lower leg 210′ or forearm 210, monitoringmuscle compartment swelling is important to reduce the incidence ofcompartment syndrome. As such, the devices of FIGS. 12A-12B may befashioned in the form of hosiery or a similar garment that cancircumferentially cover a limb. The garment/hosiery is preferablystretchable so as to provide a retentive force upon application thatwill maintain the desired position of the garment/hosiery.

Pressure sensors may be printed, heat laminated, or otherwise applied tothe fabric substrate. Sensors may be positioned and arranged to resideover limb areas to be monitored, such as over muscle compartments. Forexample, there are three muscle compartments in the forearm, and sensorsmay be located on the fabric substrate to overlie the anterior,posterior and mobile wad of the forearm to independently observe theswelling in each compartment. In the lower leg, sensors may be similarlyplaced to reside over the anterior and posterior compartment (overlying4 compartments). It is also possible to locate multiple sensors over agiven area of interest, such as over a given muscle compartment.

Such an embodiment may be left in place while subsequentcompressive/elastic dressings are placed. Similarly, such an embodimentmay be applied and left in place under a cast or splint.

Although certain exemplary embodiments are described in detail above,the scope of the invention is not considered limited by such disclosure,and modifications are possible without departing from the spirit of theinvention as evidenced by the following claims:

What is claimed is:
 1. A pressure-sensing compression bandage,comprising: a plurality of bandage layers; a plurality of pressuresensors disposed at spaced intervals along the length of at least one ofthe bandage layers, the pressure sensors comprised of force-sensingresistors whose active areas and receptor areas are printed on separatesubstrates along with associated electrical leads and adapted to detectpressures resulting from application of the pressure-sensing compressionbandage to a target object; and a monitor-controller configured toreceive electrical signals from the pressure sensors and adapted todisplay pressure readings to a user based on the received electricalsignals.
 2. The pressure-sensing compression bandage of claim 1, whereinthe plurality of bandage layers includes an inner comfort layer.
 3. Thepressure-sensing compression bandage of claim 2, further comprising atleast one therapeutic insert disposed along an interior side of theinner comfort layer.
 4. The pressure-sensing compression bandage ofclaim 3, wherein the material of the at least one therapeutic insertcarries or is impregnated with one or a combination of materialsselected from the group consisting of silicone, a steroid, zinc, anantibacterial, an antimicrobial, alginate, an enzyme, and a biologic. 5.The pressure-sensing compression bandage of claim 2, further comprisinga mild adhesive located on an interior surface of the inner comfortlayer, the adhesive disposed as a coating, or in a striped or stippledpattern.
 6. The pressure-sensing compression bandage of claim 5, whereinthe adhesive is a silicone adhesive.
 7. The pressure-sensing compressionbandage of claim 2, wherein the inner comfort layer is comprised of oneor a combination of materials selected from the group consisting ofcotton, foam, gel, silicone, elastane, nylon, spandex, viscose, andvelour.
 8. The pressure-sensing compression bandage of claim 1, whereinthe plurality of bandage layers includes an elastic compression layer.9. The pressure-sensing compression bandage of claim 8, wherein theelastic compression layer provides a graded degree of elasticity along alength direction thereof.
 10. The pressure-sensing compression bandageof claim 9, wherein the graded degree of elasticity is produced byimparting different areas of the elastic compression layer material withperforations that may vary in shape, size and/or number.
 11. Thepressure-sensing compression bandage of claim 8, wherein the elasticcompression layer is comprised of one or a combination of materialsselected from the group consisting of polyurethane, methylmethacrylate,polyethylene, silicone, polyvinylchloride, polyester, and rubber. 12.The pressure-sensing compression bandage of claim 8, wherein thematerial of the elastic compression layer carries or is impregnated withan antimicrobial substance.
 13. The pressure-sensing compression bandageof claim 1, wherein the plurality of bandage layers includes an outerlayer.
 14. The pressure-sensing compression bandage of claim 13, whereinthe outer layer includes one or more markings adapted to aid a user inproperly overlapping the pressure-sensing compression bandage duringapplication thereof to the target object.
 15. The pressure-sensingcompression bandage of claim 14, wherein the one or more markingscomprise areas of contrasting color that extend lengthwise along theouter layer.
 16. The pressure-sensing compression bandage of claim 13,wherein the outer layer is comprised of one or a combination ofmaterials selected from the group consisting of one or a combination ofelastane, polyester, nylon, cotton, velour, and carbon.
 17. Thepressure-sensing compression bandage of claim 1, wherein the activeareas and receptor areas of the plurality of force-sensing resistors areseparated by an air gap produced by the interposition of a separatormaterial between the polymeric substrates.
 18. The pressure-sensingcompression bandage of claim 17, wherein corresponding areas of thepolymeric substrates are joined so as to form a water resistant sealaround the plurality of force-sensing resistors.
 19. Thepressure-sensing compression bandage of claim 1, wherein themonitor-controller is a portable device that is configured tocommunicate with the plurality of pressure sensors by direct connectionto electrical leads associated therewith or by wireless communication.20. The pressure-sensing compression bandage of claim 19, wherein themonitor-controller is an appropriately programmed mobile phone thatcommunicates with the pressure sensors via a communication protocolselected from the group consisting of Bluetooth®, WiFi, and near fieldcommunications.
 21. The pressure-sensing compression bandage of claim 1,wherein the monitor-controller is further adapted to display a pressuregradient created along the length of the pressure-sensing compressionbandage after its application to the target object.
 22. Thepressure-sensing compression bandage of claim 21, wherein differentpressure ranges or pressure categories associated with the pressuregradient are displayable as different colors.
 23. The pressure-sensingcompression bandage of claim 1, wherein the plurality of pressuresensors are of a type selected from the group consisting of aforce-sensitive resistor, a piezoelectric sensor, and a strain gauge.24. The pressure-sensing compression bandage of claim 1, wherein thematerial used to print the force-sensing resistor components andassociated electrical leads is an ink material selected from the groupconsisting of a conductive polymer, a piezoresistive substance, adielectric material, silver, silver chloride, and carbon.
 25. Thepressure-sensing compression bandage of claim 1, wherein at least theelectrical leads remain flexible after printing.
 26. Thepressure-sensing compression bandage of claim 1, wherein the substrateis a fabric or polymeric film.
 27. The pressure-sensing compressionbandage of claim 1, wherein at least one of the substrates is laminatedto at least one bandage layer.
 28. The pressure-sensing compressionbandage of claim 1, wherein the monitor-controller is further adapted toissue an alert if a pressure reading associated with one or more of theplurality of pressure sensors is determined to be outside of apredetermined pressure range.
 29. A pressure-sensing compressionbandage, comprising: at least an inner comfort layer, an elasticcompression layer, and an outer layer; a plurality of pressure sensorsdisposed at spaced intervals along the length of the inner comfortlayer, the pressure sensors comprised of force-sensing resistors whoseactive areas and receptor areas are printed on separate substrates alongwith associated electrical leads and adapted to detect pressuresresulting from application of the pressure-sensing compression bandageto a limb of a living subject; and a monitor-controller configured toreceive electrical signals from the pressure sensors and adapted todisplay pressure readings to a user based on the received electricalsignals.
 30. A pressure-sensing compression bandage, comprising: aninner comfort layer, an elastic compression layer, and an outer layer; apressure sensor assembly associated with the inner comfort layer andadapted to detect pressures resulting from application of thepressure-sensing compression bandage to a limb of a living subject, thepressure sensor assembly further comprising: a plurality offorce-sensing resistors disposed at spaced intervals along the length ofinner comfort layer, wherein active areas and receptor areas of theforce-sensing resistors are printed from a conductive ink material onseparate substrates along with associated electrical leads, and whereinthe imprinted substrates are associated with one another in a mirroredrelationship such that the active areas on one substrate and thereceptor areas on the other substrate are aligned, in close proximity,and facing each other, so as to thereby form individual pressuresensors, a separator layer located between the associated substrates andof a thickness that will produce an air gap between the active areas andcorresponding receptor areas of each pressure sensor when thepressure-sensing compression bandage is in an unapplied state, and asealed envelope surrounding the pressure sensors, the sealed envelopeproduced by joining corresponding areas of the associated substrates;one or more markings on the outer layer, the one or more markingsadapted to aid a user in properly overlapping the pressure-sensingcompression bandage during application thereof to the limb; and amonitor-controller configured to receive electrical signals from thepressure sensors and adapted to display pressure readings to a userbased on the received electrical signals.